Trial · NCT00687102
Cognition in the Study of Tamoxifen and Raloxifene
NCT00687102, Phase 3, Completed, Wake Forest University; results first posted 2018-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cognition in the Study of Tamoxifen and Raloxifene. Trials, record NCT00687102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00687102
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cognition in the Study of Tamoxifen and Raloxifene
- NCT number
- NCT00687102
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,498 participants, actual
- Lead sponsor
- Wake Forest University
- Conditions
- Cognition, Aging
- Interventions
- tamoxifen, raloxifene
- First posted
- 2008-05-30
- Last updated
- 2018-09-12
- Results first posted
- 2018-01-23
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group | Baseline and 3 Years | Mean Change From Baseline on the Benton Visual Retention (BVRT) Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures. The BVRT measures short term visual memory and visuo-constructional abilities. Each of 10 designs was presented one at a time for 10 seconds, and immediately after the design was withdrawn, the participant was instructed to draw it from memory on a blank sheet of paper. The score on the BVRT is the total number of errors, 0-26 represents the total number of theoretically possible errors. Lower score denotes better outcomes. |
| Primary | Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group | Baseline and 3 Years | Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures. The experimenter reads a list of 16 nouns aloud, at one-second intervals, in fixed order, over 3 learning trials (list A) . After each trial, the subject is asked to recall as many words as they can in any order (i.e., free recall) given a score 0-16 each. Total range as the sum of the 3 learning trials: 0 - 48. Participants were asked to recall a second interference list (List B) with a score range of 0-16. Free recall of list A are tested immediately after list B (short-delay) Total range 0- 16 , and again after 20 minutes (long-delay) 0-16. Each part of the scale is reported separately as Total List A trials, Total List B trials, Short-delay free recall, and Long-delay free recall. |
| Secondary | Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group | Baseline and 3 Years | Mean Change From Baseline on the Letter Fluency Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures. Measures cognitive function. In this test, the participant names as many words as possible in 1 minute, beginning with each letter for letter fluency (F, A, and S) and category for semantic fluency (fruits and vegetables). To score the administrator, counts up the total number letters or words that the individual is able to produce. The score minimum would be 0 and the maximum would be the total of correct items named within 1 minute. Higher scores represent better outcomes. |
| Secondary | Mean Change From Baseline on Digit Span Test Scores by Treatment Group | Baseline and 3 Years | Mean Change From Baseline on the Digit Span Test - Digits Forward and Digits backward Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures. Measures reasoning, verbal ability, and memory. The participant is asked to provide immediate recall of a series of digits in forward and backward sequences. The individual's score is the total number of items correctly repeated forwards or backwards. Total range 0 - 14, higher results denotes a better outcome. |
| Secondary | Mean Change From Baseline on Card Rotations Test Scores by Treatment Group | Baseline and 3 Years | Mean Change From Baseline on the Card Rotations Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures. Measures the ability to mentally manipulate figures in two and three-dimensions. On each of 28 trials, participants view sample line drawings of a geometric figure and 8 alterations representing 2 or 3-dimensional rotations of the drawing. Participants are asked to identify alternatives that show the sample in 2-D but not in 3-D. Total range 0 - 160 and the number of incorrect/correct responses is measure. Higher number of correct answers is a better outcome. |
| Secondary | Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group | Baseline and 3 Years | Mean Change From Baseline on the the Finger Tapping Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures. Measures motor speed, coordination, attention, alertness, slowing of responses, and motor control. In this test of motor speed and dexterity participants are asked to depress a lever as many times as possible in each of 7, 10-second trials, first with the right hand and next with the left hand. The highest and lowest scores are dropped; the score is the average of the remaining five trials for each hand.Higher scores represent better outcomes. |
| Secondary | Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group | Baseline and 3 Years | Mean Change From Baseline on the Positive and Negative Affect Schedule (PANAS). Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures. Measures positive and negative affect. Mood is assessed with the PANAS, a list of ten pleasant mood states (e.g., interested, proud, inspired) and ten unpleasant mood states (e.g., irritable, guilty, jittery). Respondents are asked to rate on a 5-point scale (1 being "very slightly or not at all" and 5 being "extremely") the extent to which they have experienced each mood during a specific time frame. Ratings for each item can range from 0 to 4 with total scores for positive affect and negative affect subscales ranging from 0 to 40. For positive affect, higher scores denote higher levels of positive affect and for negative affect, lower scores denote lower levels of negative affect. |
| Secondary | Mean Change From Baseline on the Geriatric Depression Scale Scores by Treatment Group | Baseline and 3 Years | Mean Change From Baseline on the Geriatric Depression Scale. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures. Measures depression in older adults. Mood is also assessed with the 15-item short form of the GDS which measures non-somatic features of depressed mood. Participants indicate the presence or absence of each symptom. The GDS-SF score is the total number of positive depressive items. Score range is 0-15, with 0-4 denoting better outcomes and a score of 5 and above denoting worse outcomes (depression). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group | Baseline and 3 Years | Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial. | Number of errors | MEAN |
| PRIMARY | Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group | Baseline and 3 Years | Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial. | correct responses | MEAN |
| SECONDARY | Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group | Baseline and 3 Years | Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial. | change in number of words | MEAN |
| SECONDARY | Mean Change From Baseline on Digit Span Test Scores by Treatment Group | Baseline and 3 Years | Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline on Card Rotations Test Scores by Treatment Group | Baseline and 3 Years | Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial. | correct responses | MEAN |
| SECONDARY | Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group | Baseline and 3 Years | Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial. | finger taps | MEAN |
| SECONDARY | Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group | Baseline and 3 Years | Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline on the Geriatric Depression Scale Scores by Treatment Group | Baseline and 3 Years | Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group | Star Participants Assigned to Tamoxifen | -0.73 | Standard Error 0.34 | Number of errors | |
| Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group | Star Participants Assigned to Raloxifene | -1.41 | Standard Error 0.32 | Number of errors | |
| Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group | Star Participants Assigned to Tamoxifen | Total List A trials | -3.31 | Standard Error 0.50 | correct responses |
| Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group | Star Participants Assigned to Raloxifene | Total List A trials | -1.89 | Standard Error 0.48 | correct responses |
| Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group | Star Participants Assigned to Tamoxifen | Total List B trials | -1.56 | Standard Error 0.19 | correct responses |
| Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group | Star Participants Assigned to Raloxifene | Total List B trials | -1.74 | Standard Error 0.18 | correct responses |
| Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group | Star Participants Assigned to Tamoxifen | Short-delay free recall | -0.96 | Standard Error 0.25 | correct responses |
| Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group | Star Participants Assigned to Raloxifene | Short-delay free recall | -0.36 | Standard Error 0.24 | correct responses |
| Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group | Star Participants Assigned to Tamoxifen | Long-delay free recall | -0.23 | Standard Error 0.25 | correct responses |
| Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group | Star Participants Assigned to Raloxifene | Long-delay free recall | 0.10 | Standard Error 0.24 | correct responses |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Star Participants Assigned to Tamoxifen | 733 | |
| Overall Study | STARTED | Star Participants Assigned to Raloxifene | 765 | |
| Overall Study | COMPLETED | Star Participants Assigned to Tamoxifen | 733 | |
| Overall Study | COMPLETED | Star Participants Assigned to Raloxifene | 765 | |
| Overall Study | NOT COMPLETED | Star Participants Assigned to Tamoxifen | 0 | |
| Overall Study | NOT COMPLETED | Star Participants Assigned to Raloxifene | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Star Participants Assigned to Tamoxifen | ||
| Total, all-cause mortality | Star Participants Assigned to Raloxifene | ||
| Total, other adverse events | Star Participants Assigned to Tamoxifen | 0 | 733 |
| Total, other adverse events | Star Participants Assigned to Raloxifene | 0 | 765 |
| Total, serious adverse events | Star Participants Assigned to Tamoxifen | 0 | 733 |
| Total, serious adverse events | Star Participants Assigned to Raloxifene | 0 | 765 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R13AG020218 | 7th Annual Graylyn Conference: Women's Cognitive Health | SHUMAKER, SALLY | WAKE FOREST UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE ON AGING | 2001 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Star Participants Assigned to Tamoxifen vs Star Participants Assigned to Raloxifene: serious adverse events |
Source Trial comparisons
Tests5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Verbal Learning | Primary outcome | ConductCognition |
| Category Fluency | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Finger Tapping Task | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00687102
GET https://conductscience.org/api/trials/v1/NCT00687102/results?page=2